A Phase III, randomized, multicenter, open-label, non-inferiority study evaluating the efficacy, safety and tolerability of switching to dolutegravir/lamivudine fixed dose combination in HIV-1 infected adults who are virologically suppressed

ViiV Healthcare UK Limited0 sites490 target enrollmentJune 6, 2019

ConditionsHuman Immunodeficiency Virus-1 infection MedDRA version: 20.1Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 100000004862 Therapeutic area: Diseases [C] - Virus Diseases [C02]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Human Immunodeficiency Virus-1 infection
Sponsor: ViiV Healthcare UK Limited
Enrollment: 490
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 6, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

ViiV Healthcare UK Limited

Eligibility Criteria

Inclusion Criteria

•1\. Aged 18 years or older (or older, if required by local regulatory agencies), at the time of signing the informed consent
•2\. Adults living with HIV
•3\. Documented evidence of at least two plasma HIV\-1 RNA measurements \<50 c/mL in the 12 months prior to Screening: one within the 6 to 12 month window, and one within 6 months prior to Screening.
•4\. Plasma HIV\-1 RNA \<50 c/mL at Screening.
•5\. Must be on uninterrupted current regimen (either the initial or second cART regimen) for at least 3 months prior to Screening.
•Any prior switch, defined as a change of a single drug or multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or convenience/simplification and must NOT have been done for suspected or established treatment failure. The following switches, if they are the only switches, would not be considered a change in regimen;
•a. A switch from a PI boosted with RTV to the same PI boosted with cobicistat is allowed (and vice versa).
•b. A switch from lamivudine (3TC) to emtricitabine (FTC) (and vice versa)
•c. A switch from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide (TAF) (and vice versa).
•Acceptable stable cART regimens prior to Screening include 2 NRTIs plus:

Exclusion Criteria

•1\. Women who are pregnant or breastfeeding or plan to become pregnant or breastfeed during the study
•2\. Any evidence of an active CDC Stage 3 disease, EXCEPT cutaneous Kaposi’s sarcoma not requiring systemic therapy. Historical or current CD4 cell counts less than 200 cells/mm3 are NOT exclusionary.
•3\. Participants with severe hepatic impairment (Class C) as determined by Child\-Pugh classification.
•4\. Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•5\. Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti\-HBc), Hepatitis B surface antigen antibody (anti\-HBs) and HBV DNA as follows:
•\- Participants positive for HBsAg are excluded.
•\- Participants negative for anti\-HBs but positive for anti\-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
•Note: Participants positive for anti\-HBc (negative HBsAg status) and positive for anti\-HBs (past and/or current evidence) are immune to HBV and are not excluded. Anti\-HBc must be either total anti\-HBc or anti\-HBc immunoglobulin G (IgG), and NOT anti\-HBc IgM. Participants with a documented history of chronic HBV and current undetectable HBV DNA while on a TAF/TDF regimen are excluded.
•6\. Anticipated need for any HCV therapy during the randomized phase of the study, or anticipated need for HCV therapy with a potential for adverse drug\-drug interactions with DTG/3TC.
•7\. Untreated syphilis infection (positive rapid plasma reagin \[RPR] at Screening without clear documentation of treatment). Participants who are at least 7 days post